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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03254082
Other study ID # KSUHML10_Sorg
Secondary ID
Status Completed
Phase N/A
First received September 2, 2015
Last updated August 15, 2017
Start date September 2010
Est. completion date May 2011

Study information

Verified date August 2017
Source Kansas State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Given the interest in gluten-free foods and discovering dietary means to prevent metabolic disorders, this study was designed to determine the glycemic responses of four (4) grains and flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects and blood glucose will be collected prior to and after eating over the course of two hours. A dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as the control treatment.


Description:

Gruel was formed via a 1:9 ratio of grain (30 g) to water (270 ml) and cooked until thickened by placing water and grain mixture in a beaker and placed in a hot water bath (cooked over a stove/heating unit). The gruel was allowed to cool for 3-5 minutes before eating. The consistency of the gruel was similar to oatmeal. Subjects had a resting blood sample collected for assessment of fasting blood glucose, then ate the gruel (or control sucrose, 22g) that was assigned for that day -- they returned for the other gruel meals or sucrose control determined by Latin Square randomization. Finger stick blood samples where then collected at 30, 60, 90, and 120 minutes after eating the gruel (or sucrose) began.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Apparently healthy with no known diseases

Exclusion Criteria:

- Known metabolic, cancer, cardiovascular disease/condition

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Glycemic response of F-1000
The intervention was to determine if different flours elicit similar or different (change from baseline) 2 hour glucose responses (e.g., similar to glycemic index) after eating.
Glycemic response to sumac sorghum flour
The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sumac sorghum flour as a gruel.
Glycemic response to MMR sorghum flour
The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming MMR sorghum flour as a gruel.
Glycemic response to wheat flour
The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming wheat flour as a gruel.
Glycemic response to sucrose
The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sugar (dissolved in water)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Kansas State University United Sorghum Checkoff Program

Outcome

Type Measure Description Time frame Safety issue
Primary Blood glucose This is an acute (over 2 hours) trial to measure blood glucose (glycemic response) to food. Before eating (time 0) and 30, 60, 90, and 120 minutes after eating to measure the change in blood glucose due to the different food.
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